Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00696917

Purpose

This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Recombinant hepatitis B vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms [ Time Frame: Full course of vaccination ]
Incidence of serious adverse events [ Time Frame: Study period ]
Anti-HBs antibody concentrations [ Time Frame: At Month 7 ]

Secondary Outcome Measures:

Occurrence and intensity of solicited local signs and symptoms [ Time Frame: 4-day after vaccination ]
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms [ Time Frame: 4-day after vaccination ]
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms [ Time Frame: 30 days after vaccination ]
Occurrence and relationship to vaccination of SAEs [ Time Frame: During the study period ]
Anti-HBs antibody concentrations [ Time Frame: At Months 1, 2, 6 and 7 ]

Enrollment:	1303
Study Start Date:	April 1999
Primary Completion Date:	February 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator Three doses according to 0, 1, 6-month schedule	Biological: Engerix™-B 3-dose intramuscular injection
Group B: Experimental Two doses according to 0, 6-month schedule, with a placebo injection at Month 1	Biological: HBV-MPL vaccine 208129 2-dose intramuscular injection 3 different vaccine lots
Group C: Experimental Two doses according to 0, 6-month schedule, with a placebo injection at Month 1	Biological: HBV-MPL vaccine 208129 2-dose intramuscular injection 3 different vaccine lots
Group D: Experimental Two doses according to 0, 6-month schedule, with a placebo injection at Month 1	Biological: HBV-MPL vaccine 208129 2-dose intramuscular injection 3 different vaccine lots

Detailed Description:

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
Previous vaccination against hepatitis B.
History of non-response to previous hepatitis B vaccination.
Known exposure to hepatitis B within the past 6 weeks.
History of hepatitis B infection.
Confirmed human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
Pregnant or lactating female

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696917

Locations

Australia, Victoria
GSK Clinical Trials Call Center
Parkville, Victoria, Australia, 3052
Czech Republic
GSK Clinical Trials Call Center
Hradec Kralové, Czech Republic
Germany
GSK Clinical Trials Call Center
München, Germany
Italy
GSK Clinical Trials Call Center
Bari, Italy
Netherlands
GSK Clinical Trials Call Center
Utrecht, Netherlands
Switzerland
GSK Clinical Trials Call Center
Lausanne, Switzerland
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/031
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00696917
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Hepatitis B
Adjuvanted Hepatitis B vaccine
Recombinant Hepatitis B vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Healthy

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009